General MedicationsINTRAVENOUSStandard
RYANODEX
DANTROLENE SODIUM
Standard Dose
250MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview RYANODEX is listed in Drugs@FDA under application 205579 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DANTROLENE SODIUM Form and strength FOR SUSPENSION;INTRAVENOUS - 250MG/VIAL Sponsor EAGLE PHARMS Submission history Latest submission status date: 2024-04-02 00:00:00.
Structured Monograph
Clinical summary
Approval overview RYANODEX is listed in Drugs@FDA under application 205579 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DANTROLENE SODIUM Form and strength FOR SUSPENSION;INTRAVENOUS - 250MG/VIAL Sponsor EAGLE PHARMS Submission history Latest submission status date: 2024-04-02 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.